This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 17
Type: Topic Contributed
Date/Time: Sunday, August 1, 2010 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #307030
Title: Alternative Shelf Life Estimation Methodologies
Author(s): Walt Stroup*+ and Michelle Quinlan
Companies: University of Nebraska-Lincoln and University of Nebraska-Lincoln
Address: Department of Statistics, Lincoln, NE, 68583-0963,
Keywords: shelf life ; random batch effects ; quantile regression
Abstract:

PQRI Stability Shelf Life Working Group has worked to advance statistical methodology to estimate shelf life consistent with considerations articulated elsewhere in this session. Methodology and inference implicit in fixed and random batch approaches are examined. In some cases standard mixed model procedures suffice. Other cases require consideration of a quantile of the relevant distribution to assess whether a product meets pre specified acceptance limits. We consider fixed and random batch quantile regression. For fixed batches, standard quantile regression is useful for estimating shelf life. Random batches require new quantile techniques. Methods using existing statistical software and extension of quantile regression to random batch effects are presented. Comparison of shelf life estimation results from the various methods is made via simulation and using a real life data set.


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